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Vēl viens un kārtējais panākums
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11.07.2018


Starptautiskas zinātnieku grupas pētījums vainagojies ar panākumiem: viņu radītā pret cilvēka imūndeficīta vīrusa vakcīna Ad26 izrādījusies patiešām efektīva. Pētījuma rezultāti  publicēti žurnālā The Lancet.
Pētījums bija divkārt "aklais", jo nedz tā dalībnieki, nedz organizētāji līdz testa veikšanas beigām nezināja, kura grupa lieto vakcīnu, bet kura – "māneklīti". Pētījumā piedalījās 393 veseli brīvprātīgie vecumā no 18 līdz 50 gadiem, pārstāvot Austrumu un Dienvidāfrikas, ASV un Taizemes 12 klīnikas.
Atzīmēts, ka, spriežot pēc pētījumu rezultātiem, visas Ad26 vakcinēšanas shēmas izrādījās drošas un nekaitīgas brīvprātīgo veselībai. Tika konstatēti nenozīmīgi blakus efekti: dažiem pētījuma dalībniekiem bija sāpes injicēšanas vietā, galvas reiboņi un diareja. Vakcinācija veicināja antiķermeņu pret vīrusa olbaltumvielām skaita pieaugumu, kā arī aktīvu fagocitozi un imūnās sistēmas T-šūnu aktivizēšanos.
Bez tam zinātnieki nolēma vakcīnu pārbaudīt uz 72 makakas sugas pērtiķiem, kuriem bija tāda pati imūnās sistēmas atbilde.
Pēc pētnieku grupas vadītāja virusuloga Dena Baruša vārdiem, tā, iespējams, nebūs galīgā vakcīna, taču tā kļūs par fenomenālu izrāvienu medicīnā. Zinātnieki atzīmēja, ka pētījuma galīgie rezultāti tiks iegūti ap 2021. gadu. Tikai tad varēs runāt par vakcīnas farmaceitisko ražošanu.
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Source: MedicalXpress | «Novel HIV vaccine candidate is safe and induces immune response in healthy adults and monkeys» | https://medicalxpress.com/news/2018-07-hiv-vaccine-candidate-safe-immune.html |
<...  New research published in The Lancet shows that an experimental HIV-1 vaccine regimen is well-tolerated and generated comparable and robust immune responses against HIV in healthy adults and rhesus monkeys. Moreover, the vaccine candidate protected against infection with an HIV-like virus in monkeys.
Based on the results from this phase 1/2a clinical trial that involved nearly 400 healthy adults, a phase 2b trial has been initiated in southern Africa to determine the safety and efficacy of the HIV-1 vaccine candidate in 2,600 women at risk for acquiring HIV. This is one of only five experimental HIV-1 vaccine concepts that have progressed to efficacy trials in humans in the 35 years of the global HIV/AIDS epidemic.
Previous HIV-1 vaccine candidates have typically been limited to specific regions of the world. The experimental regimens tested in this study are based on 'mosaic' vaccines that take pieces of different HIV viruses and combine them to elicit immune responses against a wide variety of HIV strains.
"These results represent an important milestone. This study demonstrates that the mosaic Ad26 prime, Ad26 plus gp140 boost HIV vaccine candidate induced robust immune responses in humans and monkeys with comparable magnitude, kinetics, phenotype, and durability and also provided 67% protection against viral challenge in monkeys", says Professor Dan Barouch, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School, Boston, USA who led the study. ...>
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Source: The Lancet | «Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19)» | https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31364-3/abstract |
<... We conducted a multicentre, randomised, double-blind, placebo-controlled phase 1/2a trial (APPROACH). Participants were recruited from 12 clinics in east Africa, South Africa, Thailand, and the USA. We included healthy, HIV-1-uninfected participants (aged 18–50 years) who were considered at low risk for HIV-1 infection. We randomly assigned participants to one of eight study groups, stratified by region. Participants and investigators were blinded to the treatment allocation throughout the study. We primed participants at weeks 0 and 12 with Ad26.Mos.HIV (5 × 1010 viral particles per 0=5 mL) expressing mosaic HIV-1 envelope (Env)/Gag/Pol antigens and gave boosters at weeks 24 and 48 with Ad26.Mos.HIV or modified vaccinia Ankara (MVA; 108 plaque-forming units per 0=5 mL) vectors with or without high-dose (250 μg) or low-dose (50 μg) aluminium adjuvanted clade C Env gp140 protein. Those in the control group received 0=9% saline. All study interventions were administered intramuscularly. Primary endpoints were safety and tolerability of the vaccine regimens and Env-specific binding antibody responses at week 28. Safety and immunogenicity were also assessed at week 52. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. We also did a parallel study in rhesus monkeys (NHP 13-19) to assess the immunogenicity and protective efficacy of these vaccine regimens against a series of six repetitive, heterologous, intrarectal challenges with a rhesus peripheral blood mononuclear cell-derived challenge stock of simian-human immunodeficiency virus (SHIV-SF162P3). ...>




 
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